Recall Z-2535-2024— LINEAGE BIOMEDICAL, INC

Name: FDA recall Z-2535-2024
Creator: U.S. Food and Drug Administration
Published: 2024-07-12

Class III · Ongoing

Class III FDA medical device recall by LINEAGE BIOMEDICAL, INC, initiated 2024-07-12. It names one FDA 510(k) clearance: K231877. Product: NavaClick Syringe and Needle, Model Number LIN02. Reason: Incorrect GTIN number on carton..

Recalling firm: LINEAGE BIOMEDICAL, INC
Classification: Class III
Status: Ongoing
Initiated: 2024-07-12
Firm location: Stuart, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K231877 — NavaClick Injection SystemLineage Biomedical, Inc.·cleared 2023-11-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

NavaClick Syringe and Needle, Model Number LIN02

Reason for recall

Incorrect GTIN number on carton.

Data sourced from openFDA. This site is unofficial and independent of the FDA.